Safety and Efficacy Study of Photopheresis Plus Standard Therapy to Treat Chronic Graft-Versus-Host Disease - Full Text View

Sponsor:	Therakos
Information provided by:	Therakos
ClinicalTrials.gov Identifier:	NCT00054613

Purpose

The purpose of this study is to determine whether extracorporeal photoimmune therapy with UVADEX (ECP) added to standard therapy is effective in the treatment of chronic graft-versus-host disease (GvHD).

Condition	Intervention	Phase
Graft-Versus-Host Disease	Drug: Methoxsalen Procedure: Extracorporeal Photopheresis	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Single-Blind Study of Extracorporeal Photoimmune Therapy With UVADEX in Conjunction With Standard Therapy Alone for the Treatment of Patients With Corticosteroid-Refractory, Corticosteroid-Dependent, or Corticosteroid-Intolerant Chronic Graft-Versus-Host Disease

Resource links provided by NLM:

Drug Information available for: Methoxsalen

U.S. FDA Resources

Further study details as provided by Therakos:

Estimated Enrollment:	72
Study Start Date:	June 2002
Estimated Study Completion Date:	March 2004

Detailed Description:

For patients who survive allogeneic bone marrow transplants greater than 100 days, chronic GvHD is a major cause of non-relapse morbidity and mortality. Depending on the presence of known associated risk factors, chronic GvHD will occur in 20-50% of these transplant recipients, with mortality rates varying from 20 to 70%.

Because a lymphocyte-mediated immune reaction is thought to be involved in GvHD, suppression of these cells by means other than medications could have benefit in the GvHD population.

ECP is a technique in which peripheral white blood cells are exposed to a photoactivatable compound (UVADEX) administered extracorporeally and ultraviolet A light. After cells are reinfused into the patient, their function is altered, thereby activating mechanisms that allow for further regulation of specific lymphocyte populations.

The purpose of this study is to determine whether ECP, in conjunction with standard therapy, is effective in the treatment of chronic GvHD. Efficacy of the therapy with respect to skin manifestations of the disease will be determined by a blinded skin assessor.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented skin disease classical for chronic GvHD (e.g. hypopigmentation, hyperpigmentation, lichenoid lesions, sclerodermatous lesions)greater than or equal to 100 days post transplantation.
Patients with documented chronic GvHD that is corticosteroid refractory, corticosteroid dependent or corticosteroid intolerant.
Women of childbearing potential must agree to use a reliable method of birth control for the duration of this study.
Patients must weight at least 40 kg (88 lbs.)

Exclusion Criteria:

Active gastrointestinal bleeding
Previous treatment with ECP
Females who are pregnant and/or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054613

Show 31 Study Locations

Sponsors and Collaborators

Therakos

More Information

Publications:

Smith EP, Sniecinski I, Dagis AC, Parker PM, Snyder DS, Stein AS, Nademanee A, O'Donnell MR, Molina A, Schmidt GM, Stepan DE, Kapoor N, Niland JC, Forman SJ. Extracorporeal photochemotherapy for treatment of drug-resistant graft-vs.-host disease. Biol Blood Marrow Transplant. 1998;4(1):27-37.

Greinix HT, Volc-Platzer B, Knobler RM. Extracorporeal photochemotherapy in the treatment of severe graft-versus-host disease. Leuk Lymphoma. 2000 Feb;36(5-6):425-34. Review.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Flowers ME, Apperley JF, van Besien K, Elmaagacli A, Grigg A, Reddy V, Bacigalupo A, Kolb HJ, Bouzas L, Michallet M, Prince HM, Knobler R, Parenti D, Gallo J, Greinix HT. A multicenter prospective phase 2 randomized study of extracorporeal photopheresis for treatment of chronic graft-versus-host disease. Blood. 2008 Oct 1;112(7):2667-74. Epub 2008 Jul 11.

Study ID Numbers:	GvHD-SK1
Study First Received:	February 5, 2003
Last Updated:	January 6, 2006
ClinicalTrials.gov Identifier:	NCT00054613 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Therakos:

Graft-versus-Host Disease
Extracorporeal Photopheresis

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Immune System Diseases
Methoxsalen
Therapeutic Uses

Physiological Effects of Drugs
Graft vs Host Disease
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009